CALiBRe: Assessment of the Mechanism of Action of idelalisib (CAL-101) in B-cell Receptor Pathway Inhibition in C

Phase 1

• Conditions: Chronic lymphocytic leukaemia; MedDRA version: 21.1 Level: LLT Classification code 10068852 Term: B-cell chronic lymphocytic leukaemia System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003631-36-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-10
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. Chronic lymphocytic leukaemia requiring therapy
2. Relapsed/refractory CLL defined as any of the following:
- Failure to achieve a response (CR or PR) to, or progression during or after, ibrutinib (or an alternative Btk inhibitor)
Or:
- Patients who are unable to tolerate ibrutinib (or an alternative BTK inhibitor) or in whom it is contraindicated.
_And_ where at least one of the following criteria apply
• Patients with CLL with deletion of chromosome 17p who have failed at least one previous therapy
• Failure to achieve a response (CR or PR by IWCLL criteria) to a purine analogue alone or in combination with chemotherapy, or:
• Relapse within 6 months of responding to a purine analogue alone or in combination with chemotherapy, or:
• Relapse at any time after fludarabine, cyclophosphamide and rituximab (FCR) or chemotherapy plus rituximab (or an alternative anti-CD20 antibody):
3. ECOG performance status (PS) of 0, 1, or 2 (see Appendix 5).
4. Life expectancy of at least 6 months
5. Prepared to undergo the stipulated investigations within the trial (including bone marrow examinations)
6. Age =18
7. Able to give informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Previously untreated for CLL
2. Unwilling to undergo the protocol assessments including the bone marrow assessments
3. Active infection at the time of registration, history of chronic or recurrent infection
4. Other severe, concurrent (particularly cardiac or pulmonary) diseases or mental disorders that could interfere with their ability to participate in the study
5. Use of prior investigational agents within 6 weeks
6. Pregnancy or lactation
7. Unwilling to use appropriate contraception during and for 30 days following treatment
8. CNS involvement with CLL
9. Mantle cell lymphoma
10. Known HIV positive
11. Active or prior Hepatitis B or C
12. Active secondary malignancy excluding basal cell carcinoma
13. Persisting severe pancytopenia (neutrophils <0.5 x109/L) or transfusion dependent anaemia unless due to direct marrow infiltration by CLL. This is to be confirmed via bone marrow biopsy.
14. Active haemolysis (not controlled with prednisolone at 20mg or less)
15. Hypersensitivity to idelalisib or to any of the excipients listed in the Summary of Product Characteristics (SmPC)
16. Previous treatment with idelalisib or another PI3K inhibitor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified